Module 18 2021

MDR & IVDR will not apply in Great Britain

MDR

IVDR

• Applies in the EU on 26 May 2021 – outside of transition period

• Applies in the EU on 26 May 2022 – outside of transition period

• Not automatically retained by the EU

• Not automatically retained by the EU

Withdrawal Agreement Act

Withdrawal Agreement Act

5

5

Legislation that will apply in Great Britain

Medical Devices Directive

Active Implantable

Medical Devices Directive

In vitro Diagnostic Medical Devices Directive

UK Medical Devices Regulations 2002 (in the form they exist on 1 January 2021)

6

6

3